Events

Device Recall Halo Closed System Transfer Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 J&J; Solutions, Inc. DBA Corvida Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    75810
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1003-2017
  • 사례 시작날짜
    2016-11-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151346
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
  • 원인
    Product malfunction: needle does not retract.
  • 조치
    Corvida Medical sent an Urgent Notice: Medical Device Recall letter dated November 22, 2016, to all affected customers. After completing a Health Hazard Evaluation, recalling firm drafted a Recall Notification by Phone script. on November 21 2016, utilizing the script, the Vice President of Sales contacted all parties (customers) who received the recalled lot. He confirmed each customers understanding of the recall notification and forwarded the contact records to the Recall Coordinator. If you have further questions , please contact your Sales Representative or Corvida Customer Service at (800) 651-6832.

Device

Device Recall Halo Closed System Transfer Device
  • 모델명 / 제조번호(시리얼번호)
    Lot 0610525, 2017-10-18
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
  • 제품 설명
    Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
  • Manufacturer
    J&J; Solutions, Inc. DBA Corvida Medical

Manufacturer

J&J; Solutions, Inc. DBA Corvida Medical
  • 제조사 주소
    J&J; Solutions, Inc. DBA Corvida Medical, 2261 Crosspark Rd Ste 127, Coralville IA 52241-4716
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA